A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

Exclusion Criteria

• •Patients who meet any of the following criteria cannot be enrolled:
• •1. Pregnant or breastfeeding females.
• •2. Childbearing potential who does not agree to the use of contraception during the treatment period..
• •3. Treatment with any investigational drug within washout period.
• •4. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
• •5. Central nervous system disease involvement
• •6. History or risk of autoimmune disease.
• •7. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
• •8. Patients requiring systemic treatment with corticosteroids
• •9. Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
• •10. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
• •11. Major surgery within 4 weeks prior to the first dose of the study drug.
• •12. Has had an allogeneic tissue/solid organ transplant.